• GMP manufacturing completed, paediatric waiver granted, positive outcome from FDA and EMA interactions; advancing mitazalimab toward Phase 3 readiness
• Biomarker data from OPTIMIZE-1 presented at ASCO, supporting patient stratification and clinical potential
• Warrant programme TO 12 completed, with gross proceeds of SEK 61 million and further strengthening financial position

Lund, Sweden – Alligator Bioscience (Nasdaq Stockholm: ATORX)

"With key regulatory and manufacturing milestones achieved for mitazalimab and strengthened financials, we remain focused on identifying a strategic partner and initiating Phase 3. During the quarter, we successfully completed GMP manufacturing and received clear regulatory feedback from both the FDA and EMA—confirming dose, trial design and paediatric waiver—further strengthening the program’s foundation. In parallel, new biomarker data presented at ASCO reinforced mitazalimab’s clinical potential and relevance for patient stratification. Combined with the proceeds from TO 12, these developments move us into the next exciting stage of mitazalimab’s journey."
Søren Bregenholt, CEO of Alligator Bioscience

BUSINESS UPDATE
Mitazalimab

• Completion of GMP manufacturing for mitazalimab to support Phase 3 trial readiness in collaboration with development partner.
• Paediatric study waiver granted by the European Medicines Agency, streamlining regulatory path ahead of future MAA submission.
• Presentation of biomarker data from the Phase 2 trial OPTIMIZE-1 at ASCO 2025, showing mitazalimab-induced immune modulation and identifying biomarkers linked to improved outcomes in metastatic pancreatic cancer.
• Confirmation from FDA of 900 ug/kg dose and positive scientific advice from EMA further strengthen mitazalimab’s regulatory foundation ahead of Phase 3.

Company

• Annual General Meeting held on 7 May 2025; adoption of updated dividend policy aligned with sharpened strategic focus and potential proceeds from asset monetization.
• Execution of 1:1000 reverse share split in April 2025, followed by recalculation of terms for TO 12 and TO 13 warrants.
• Successful completion of warrant programme TO 12 in May 2025, with 71% of options exercised and SEK 61 million raised before issue costs and partial repayment of loan.
• Adjustment of total number of shares to 34,803,898 following TO 12 warrant exercise and share split.
• Initiation of Phase 2 clinical trial with HLX22 in HER2-positive breast cancer by Shanghai Henlius; EU Orphan Drug Designation granted for HLX22 in gastric cancer.

FINANCIAL SUMMARY FOR Q2 2025
The financial summaries for the quarterly periods ending 30 June 2025 and 30 June 2024 are presented below.

FINANCIAL SUMMARY FOR H1 2025
The financial summaries for the half-year periods ending 30 June 2025 and 30 June 2024 are presented below.

The full report is attached as a PDF, and is also available on the company’s website: https://alligatorbioscience.se/en/investors/financial-reports/

Alligator will host a webinar on Thursday, July 10 2025, at 3 p.m. CEST/ 9 a.m. EDT for investors, analysts and media, where CEO Søren Bregenholt and CFO Johan Giléus will present and comment on the April – June 2025 interim report, which will be followed by a Q&A session.

The call will be held in English. Attendees need to register by following this link.